Study of the treatment of patients with non-small cell lung cancer with metastasis with Cemiplimab and subsequent treatment with Cemiplimab or Cemiplimab combined with chemotherapy according to levels of tumor DNA circulating in the blood

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fundacion GECP

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

2 Jul 2025 → ongoing

Decision date (initial)

2025-03-26

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Fundación GECP

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy, Efficacy

The primary research goal is to determine whether therapy decision making based on ctDNA analysis improves OS. In this way, we will test whether the addition of chemotherapy in patients receiving Cemiplimab, based on the ctDNA levels after two cycles of Cemiplimab, improves OS at 24 months.

Secondary objectives 6

1. 1. Duration of response (DOR)
2. 2. Overall survival (OS) at 12, 36 and 48 months
3. 3. Progression free survival (PFS) at 12, 24, 36 and 48 months
4. 4. Sites of first failure
5. 5. Overall response rate (ORR)
6. 6. Toxicity profile

Conditions and MedDRA coding

Non-small cell lung cancer (NSCLC)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 13

1. 1. Histologically confirmed stage IV or stage IIIB/C not candidates for definitive chemo/radiotherapy or surgical resection non-small cell lung cancer (NSCLC) per the 8th edition TNM with no prior systemic anti-cancer therapy
2. 2. PDL1 ≥ 50%
3. 3. ECOG performance status 0-1
4. 4. Patients aged ≥ 18 years
5. 5. Prior definitive chemoradiation for locally advanced disease is permitted as long as the last administration of chemotherapy or radiotherapy occurred at least 6 months prior to enrolment. Also, patients treated with immunotherapy or chemo-immunotherapy Combinations at least 6 months prior to enrollment can be included in the study
6. 6. Prior adjuvant or neoadjuvant chemotherapy or chemo-immunotherapy for early stage is permitted if completed at least 6 months prior to enrolment
7. 7. Presence of at least one measurable lesion by computed tomography (CT-scan) per response evaluation criteria in solid tumors (RECIST) version 1.1
8. 8. Anticipated life expectancy >12 weeks
9. 9. Correct hematological, hepatic and renal function
10. 10. Patient consent must be obtained in the appropriate manner as established in the applicable local and regulatory requirements
11. 11. Patients must be accessible for treatment and follow-up
12. 12. Women of childbearing potential, including women who had their last menstrual period in the last 2 years, must have a negative serum or urine pregnancy test within 3 days before enrolment
13. 13. All sexually active men and women of childbearing potential must use a highly effective contraceptive method (<1% failure rate) during the study treatment and for a period of at least 5 months for females and 7 months for males following the last administration of trial drugs

Exclusion criteria 24

1. 1. Patients whose tumors harbor an activating mutation in epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK) translocation, or ROS Proto-Oncogene 1 (ROS1) rearrangements sensitive to available targeted inhibitor therapy
2. 10. Patients who have received prior neo-adjuvant, adjuvant chemotherapy, radiotherapy, chemo-radiotherapy or chemo-immunotherapy with curative intent for non-metastatic disease less than 6 months before enrollment since the last chemotherapy, radiotherapy, or chemo-radiotherapy
3. 11. Patients with a combination of small cell lung cancer and non-small cell lung cancer, a carcinoid lung tumor or large cell neuroendocrine carcinoma
4. 12. Has known allergy or hypersensitivity to components of study drug
5. 13. Significant comorbidities that preclude the administration of chemotherapy according to the investigator’s criteria
6. 14. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-mediated adverse events (imAEs). The following are not exclusionary: vitiligo, childhood asthma that has resolved, type 1 diabetes, residual hypothyroidism requiring only hormone replacement, or psoriasis that does not require systemic treatment
7. 15. Untreated brain metastasis(es) that may be considered active or symptomatic. Note in clarification: Patients with previously treated brain metastases may participate provided that the lesion(s) is (are) stable (without evidence of progression for at least 6 weeks on imaging obtained in the screening period)and there is no evidence of new or enlarging brain metastases and the patients do not require any immunosuppressive doses of systemic corticosteroids for management of brain metastasis(es) within 28 days of the first dose of REGN2810cemiplimab
8. 16. Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of REGN2810cemiplimab. Note in clarification: Patients who require brief courses of steroids (eg, as prophylaxis for imaging studies due to hypersensitivity to contrast agents) are not excluded
9. 17. Any infection requiring hospitalization or treatment with IV anti-infectives within 2 weeks of first dose of study medication
10. 18. Uncontrolled infection with HIV, hepatitis B or hepatitis C, diagnosis of immunodeficiency and/or tuberculosis (active or latent)
11. 19. History of interstitial lung disease (eg, idiopathic pulmonary fibrosis, organizing pneumonia) or active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management. A history of radiation pneumonitis in the radiation field is permitted as long as pneumonitis resolved ≥6 months prior to inclusion
12. 2. Patients with grade ≥2 neuropathy
13. 20. History of documented allergic reactions or acute hypersensitivity reactions attributed to antibody treatments
14. 21. Presence of cardiovascular disease, as defined by: a. New York Heart Association heart failure classifications of Class II, III, or IV; or myocardial infarction, or acute coronary syndrome within 12 months of first dose of study medication; or b. Transient ischemic attack or stroke within 1 year
15. 22. Patients with a history of solid organ transplant (patients with prior corneal transplants may be allowed to enroll after discussion with and approval from the medical monitor)
16. 3. Pregnant or breastfeeding women
17. 4. Patients with a weight loss >10% within the previous 3 months
18. 5. Patients with carcinomatous meningitis
19. 6. Patients with a history of other malignant diseases within the past 3 years, with the exception of the following: - properly treated non-melanotic skin cancer - cancer in situ treated with curative intent - nonmuscularis propia invasive carcinoma of the bladder - or other malignancies treated with curative intent and without signs of disease for a period of > 3 years after the end of the treatment and which, in the opinion of the physician in charge of their treatment, do not present a substantial risk of relapse of the previous malignant disease
20. 7. Patients must have recovered from a major surgery at least 14 days prior to enrolment
21. 8. Patients with active or uncontrolled infections or with serious medical conditions or disorders that may not allow patient management as established in the protocol
22. 9. Prior treatment with antineoplasic drugs or thoracic radiotherapy for any reason different from the ones specific in the inclusion criteria
23. 23. Receipt of live vaccines (including attenuated) within 30 days of first study treatment. Receipt of COVID-19 vaccination within 1 week of planned start of study medication or for which the planned COVID-19 vaccinations would not be completed 1 week prior to start of study medication.
24. 24. Women of childbearing potential (WOCBP), or sexually active men, who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment prior to the start of the first treatment, during the study, and for at least 4 months after the last dose

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. OS at 24 months in the intention to treat (ITT) population

Secondary endpoints 6

1. 1. Duration of response (DOR)
2. 2. Overall survival (OS) at 12, 36 and 48 months
3. 3. Progression free survival (PFS) at 12, 24, 36 and 48 months
4. 4. Sites of first failure
5. 5. Overall response rate (ORR)
6. 6. Toxicity profile

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fundacion GECP

Sponsor organisation

Fundacion GECP

Address

Avinguda Meridiana 358 6 Planta

City

Barcelona

Postcode

08027

Country

Spain

Scientific contact point

Organisation

Fundacion GECP

Contact name

Mariano Provencio

Public contact point

Organisation

Fundacion GECP

Contact name

Maria Fernández

Locations

1 EU/EEA country · 20 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 13 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications